Chronic Pain and Vitamin D

NCT02002000 | Unknown

• 1 other identifier: 2013-802
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. The possible causes are numerous and sometimes nonspecific. In some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. Several studies have shown a link between these symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D \< 20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D supplementation with few side effects. Nevertheless, it remains unknown and vitamin D deficiency is rarely considered as a possible etiology in patients with chronic pain. We hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin D could improve painful symptoms. We aim to perform a double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain improvement after vitamin D supplementation.

Conditions

Chronic Musculoskeletal Pain; Vitamin D Supplementation

Keywords

Vitamin D deficiency; Musculoskeletal pain; Vitamin D supplementation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in the two groups who reported a decrease in the overall pain after 3 months of treatment with vitamin D versus placebo.

  item 5 of the Brief Pain Inventory will be measured in each patient to assess the overall pain score at inclusion and after 3 month of treatment with vitamin D or placebo

  3 months after inclusion

Secondary Outcomes (5)

• : Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain

  3 months after inclusion

• Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities

  3 months after inclusion

• Proportion of patients reporting a decrease in the consumption of analgesic drugs

  3 months after inclusion

• Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)

  3 months after inclusion

• Proportion of patients in both groups reporting an improvement in quality of life

  3 months after inclusion

Study Arms (2)

vitamin D

EXPERIMENTAL

Patients receiving 3 doses of vitamin D (cholecalciferol)

Drug: vitamin D (cholecalciferol)

Placebo

EXPERIMENTAL

Patients receiving 3 doses of placebo according to the same schedule as experimental arm

Drug: Placebo, similar in appearance and taste to cholecalciferol

Interventions

vitamin D (cholecalciferol) DRUG

Patients from the vitamin D arm will receive an orally supplementation of 600 000 UI cholecalciferol in 3 doses: 200 000 UI at baseline (day 1), 200 000 UI on day 15 and 200 000 UI on day 30. Cholecalciferol will be presented in blisters, in a non-differentiable form in appearance and taste from placebo, either for the patient or the doctor

vitamin D

Placebo, similar in appearance and taste to cholecalciferol DRUG

Patients from the placebo arm will receive 3 doses of placebo to be taken orally: one at baseline (day 1), one on day 15, one on day 30. Placebo will be presented in blisters in a non-differentiable form in appearance and taste from cholecalciferol either for the patient or the doctor.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men
• Aged 18-50 years (included)
• Consulting their general practitioner
• With chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months
• Who signed the consent form

You may not qualify if:

• Identifiable source of pain requiring an appropriate specific management
• Disease or treatment that may interfere with the metabolism of vitamin D
• Current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis
• Current treatment with vitamin D or at least one vitamin D vial taken over the previous 6 months
• Pregnancy or breastfeeding
• not affiliated to a social security system
• Refusal or inability to give consent

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Lyon, 69424, France

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Musculoskeletal Pain

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Anne-Marie SCHOTT, Pr

  Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Marie SCHOTT, Pr

CONTACT

472115371; anne-marie.schott-pettelaz@chu-lyon.fr

Julie Haesebaert

CONTACT

472115371; julie.haesebaert@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

FR (1)